Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery

November 15, 2016 updated by: Hongwen Ji

Prospective Randomized Trial of Autologous Platelet Rich Plasma in Reducing Allogeneic Transfusions During Aortic Surgery Under Deep Hypothermic Circulatory Arrest

The purpose of this study is to determine whether autologous platelet rich plasma (APRP)is effective in reducing allogeneic blood transfusions during aortic surgery using deep hypothermic circulatory arrest.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing elective or emergency aortic surgery using deep hypothermic circulatory arrest、
  • preoperative platelet counts>150000000000/L、
  • preoperative hematocrit>33%、
  • without recent anticoagulants less than 5 days

Exclusion Criteria:

  • preoperative coagulation disorder
  • severe renal and liver dysfunction
  • preoperative hemodynamic instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APRP group
APRP group is performed autologous platelet-rich plasma harvest technique before administration of heparin to the patient,the red blood cell(RBC) component is retransfused to the patient when the RBC transfusion protocol is reached,and the autologous platelet-rich plasma is transfused to the patient immediately after heparin is neutralized with protamine.
Device: Autologous Platelet-Rich Plasma Harvest Technique
15 to 20 mL/kg of whole blood is collected before the administration of heparin from a large-bore central venous access,and is separated into red blood cells component and autologous platelet-rich plasma component by an autologous transfusion system(Sorin Group Electa Essential; Sorin Group Italia, Milan, Italy).
Other Names:
  • neutralizing heparin with protamine
No Intervention: control group
APRP group receive no autologous platelet-rich plasma harvest technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total perioperative allogenic transfusions of platelet and fresh frozen plasma
Time Frame: on the 7th day postoperatively
on the 7th day postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative blood loss
Time Frame: on the 7th day postoperatively
on the 7th day postoperatively
rate of reexploration for bleeding
Time Frame: on the 7th day postoperatively
on the 7th day postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hongwen Ji

Investigators

  • Principal Investigator: Yongyuan Wang, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimate)

August 3, 2015

Study Record Updates

Last Update Posted (Estimate)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-zx011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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